Technical Documentation Assessor – Part-time

Job title: Technical Documentation Assessor – Part-time

Job description: Job Description:

Intertek is looking for Technical Documentation Assessors (TDA) who are experienced individuals focused on delivering accurate and robust assessments of our client’s technical documentation under the MDD (93/42/EEC) and the MDR (2017/745) for EC certification.

The role is a part-time remote/home-based position, with some travel required.

What you’ll do:

The Technical Documentation Assessor (TDA) will lead and/or participate in the assessment of Technical Documentation within agreed timescales and will be responsible for submission of an accurate and sufficiently detailed Technical Documentation report. As a TDA, you will also be responsible for reviewing any client responses that may be received, and you will interact on a frequent basis with internal and external people including our customers, other members of the Notified Body team and management.

DUTIES:

• Perform pre-assessments and conformity assessment of client technical documentation (TD) to the requirements of the EU MDD and MDR, according to processes and procedures, including:

• Document the above assessments and reviews in accordance with the appropriate current local and global Intertek issued processes and complete them in timely manner.
• Identify and document non-conformities as necessary.
• As part of the conformity assessment and where approved to do so, review conformity of microbiology and sterilization, biocompatibility and/or clinical data evaluation
• Liaise with the client to address any findings in a timely manner.
• Lead and manage the technical assessment team (all assessors involved in the TD review) when required by the assessment project.
• Perform quality checks, peer-review, and/or sign-off of other assessor’s assessments prior to submission of report to client
• Raise suspension documentation as needed where findings are not adequately addressed.
• Perform reviews of client’s Change Notices, making recommendations for Certification Authority personnel on proposed actions.
• Perform technical assessments of client’s vigilance reports and determine next actions, including making certification recommendations.
• As required, support audits of client management systems
• Maintain accurate and current training and assessment history records as part of ongoing competency evidence and development
• Assist, support, and attend all calibration sessions/assessor conferences, department meetings, and assessor team meetings.

What it takes to be successful in this role:

• 4 year college/university degree in a science or technical field in relevant sciences, for example medicine, pharmacy, computer and software technology, engineering, biology, microbiology, chemistry, materials science, veterinary medicine, physiology, toxicology, human physiology; pharmacy; physics, or equivalent combination of relevant education and work experience.
• A minimum of 4 years’ experience in the design, manufacture, testing and/or clinical use of medical devices.

• Work in medical devices industry or closely related industries such as research and development, manufacturing, quality management, regulatory affairs;
• Work in health services, universities, foundations, or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
• Work in the application of device technology and its use in health care services and with patients;
• Testing devices for compliance with the relevant national or international standards;
• Conducting performance testing, evaluation studies or clinical trials of devices.
• Knowledge on EU devices legislation, harmonised standards and relevant guidance documents including knowledge on the general safety and performance requirements, risk management, clinical evaluation.
• Proficiency in the English language, and strong communications and interpersonal skills.
• Results oriented, sound judgment, organizational, and analytical skills.
• Excellent computer and writing skills.
• Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to see the detail and the bigger picture.
• Ability to exercise effective time management skills in completion of assignments.
• Ability to work independently and in teams
• Must be willing and able to travel. Primarily domestic travel, some international travel may be needed.

PREFERRED:

• Prior experience working at a Notified Body as a product specialist / Technical Documentation Assessor
• Related 3rd party auditing industry management systems experience.
• Working knowledge of non-EU relevant regulatory requirements for medical devices (US, Australia, Japan, Brazil, and/or Canada.)
• Experience implementing/auditing to ISO 13485, ISO 14971, and medical device, regulatory requirements.
• Specific experience/training on processes used in the relevant industry’s manufacturing (ex. sterilization).
• Working experience in a wide range of medical devices.

PHYSICAL REQUIREMENTS:

This role requires:

• The ability to express or exchange ideas by means of the spoken word. Must be able to convey detailed or important spoken instructions or information to others accurately, loudly, or quickly.
• The ability to hear & perceive the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound, perceiving sounds, including the ability to receive information thru oral communications.
• The ability for visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
• The ability to walk, moving on foot to accomplish tasks and to move from one work location to another.
• The ability to travel via airplane.

Why work at Intertek?

Intertek is a world leader in the $250 billion Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. At Intertek, we exercise our spirit of innovation, the passion of our people and our unmatched customer commitment to realize our purpose of making the world an ever better, safer, and more sustainable place for all. Learn more about and .

Intertek is committed to a safe work environment for our employees and clients. Learn more about our .

What we have to offer:
Intertek is a drug-free workplace. As a condition of employment, all hires are required to pass a pre-employment drug test.

Intertek believes that are our strongest tool for success. We are an and do not discriminate against applicants due to veteran status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, or gender identity.

For individuals with disabilities who would like to request an accommodation, or who need assistance applying, please email or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.

About Us: Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers’ operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.

About the Team: The Business Assurance group of Intertek provides a full range of business process audit and support services, including management systems certification, sustainability and responsible sourcing audits, risk management, and training. Our range of bespoke auditing, performance benchmarking and supply chain solutions provide insight into every aspect of operations, allowing clients to make informed decisions about their business while ensuring their workforce competencies are current and relevant.

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